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FDA 510(k)

SPECTACLES LENS

K-Number: K860955 · 1986-03-31

ApplicantRoseburg SA
Decision Date1986-03-31
Product CodeHQG
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SPECTACLES LENS is the device name listed in this FDA 510(k) record. The listed applicant is Roseburg SA. It received FDA 510(k) clearance on 1986-03-31 under 510(k) number K860955. The device is classified under product code HQG. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPECTACLES LENS?

SPECTACLES LENS is a medical device that received FDA 510(k) clearance on 1986-03-31. The listed applicant is Roseburg SA. The 510(k) number is K860955.

When did SPECTACLES LENS receive FDA 510(k) clearance?

SPECTACLES LENS received FDA 510(k) clearance on 1986-03-31, under 510(k) number K860955.

Who is the listed applicant for SPECTACLES LENS?

The FDA 510(k) record lists Roseburg SA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPECTACLES LENS?

The FDA product code for SPECTACLES LENS is HQG.

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Other records listing Roseburg SA as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K931155STAPLE, FIXATION BONE; SCREW FIXATION BONEK890081CALIUS-ISABEL CANOVAS SUNGLASSESK885275ASSENAT-BLESCHET SUNGLASSESK882392BURNET LABORATOIRE PHARMACEUTIQUE SURGICAL GLOVESK872715UNIVERSAL INSTRUMENTATION(CD) FOR SPINAL SURGERYK874317POIRIER KID-ROLLER MANUAL WHEELCHAIR

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Related Devices (Code: HQG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K935919SUNGLASSESJa-Ru, Inc.K9207950R 160, OR-1.60, AND ORCOLITE 1.60 HIGH INDEXOptical Radiation Corp.K900091MODIFIED OPHTHALMIC OPIR ONUFRYK IMAGE DEFLECTOROnufryk Low Vision Ent.K884360SEIKO P-6 PROGRESSIVE SPECTACLE LENSESSeiko Corp.K882814NEOLENS PRESCRIPTION SPECTACLE LENSNeolens, Inc.K882308CR-39 PLASTIC LENSES FOR EYEGLASSESAutomated Lens System

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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